Effective March 31, 2019, FDA will begin operational implementation of an agency reorganization. FDA’s reorganization reflects the agency’s commitment to modernizing its structure to advance its mission to protect and promote public health, and to meet the challenges of rapid innovation across the industries regulated by FDA. The FDA’s reorganization will realign several entities across the agency to promote strategic priorities, and will elevate the role of the centers, offices and field forces.
This organization chart reflects the new structure under which FDA will operate.
The intent of this Compendium is to provide access to FDA regulatory methods currently being used for food and feed safety programs, including a searchable archive of validated methods and links to other on-line manuals/compendia of methods. We also provide links to the Method Development, Validation, and Implementation (MDVIP) guidelines of the Office of Foods and Veterinary Medicine (OFVM), as well as a list of methods currently undergoing validation. Prior to selecting a method for use, one must consider whether a method is fit for its intended purpose (“fit for use”), the intended matrix, instrumentation availability and suitability, the expertise of laboratory personnel, and other factors.
This web page is a work-in-progress, and methods will be added over the coming months. FVM programs currently have many methods that have been in use since before the implementation of the of the MDVIP guidelines in 2014. These older methods are currently being prioritized for evaluation prior to posting, to ensure the level of validation and the method format. Some of the methods will require evaluation of laboratory verification and quality control data before posting. All methods following the current guidelines will be posted at regular intervals following final review, approval, and formatting. Future plans include the addition of a search function, once additional methods have been uploaded or linked.
The documents below represent internal procedures and guidance for the Foods and Veterinary Medicine (FVM) Method Development, Validation, and Implementation Program (MDVIP) in the FDA Office of Foods and Veterinary Medicine (OFVM). They are made available for informational and reference purposes only.
This document establishes and describes the standard operating procedure (SOP) for the approval and tracking of FVM Program analytical method development proposals for implementation in U.S. Food and Drug Administration (FDA or the Agency) laboratories for regulatory compliance, enforcement and surveillance purposes. An important component of this process will include coordinated alignment of the method(s) to be developed with Center and Program needs and with identified Agency priorities.
To ensure that all laboratory methods meet the highest analytical standards possible for their intended purpose, OFVM through the FVM Science and Research Steering Committee (SRSC) has established these criteria by which all FVM microbiological methods shall be evaluated and validated.
To ensure that the chemical methods employed for the analysis of foods and feeds meet the highest analytical performance standards appropriate for their intended purposes, OFVM through the SRSC has established criteria by which all Foods and Veterinary Medicine (FVM) Program chemical methods shall be evaluated and validated. This document defines four standard levels of performance for use in the validation of analytical regulatory methods for chemical analytes in foods and feeds.
To ensure that the methods employed in Foods Program laboratories meet the highest analytical performance standards, the Foods Program Regulatory Science Steering Committee (RSSC) here establishes criteria by which all analytical methods for targeted nucleic acid sequence-based analyses in food, feed, cosmetics, and veterinary products to be used in FDA laboratories shall be evaluated and validated. This document defines four standard levels of performance for use in the validation of analytical methods for the detection, identification, and/or quantification of specific DNA sequences in food, feed, cosmetics, and veterinary products.
In 2002 the FDA Center for Veterinary Medicine (CVM) published Guidance for Industry (#118) titled "Mass Spectrometry for Confirmation of the Identity of Animal Drug residues." Details of criteria for various types of unit-resolution mass spectrometry (MS) were given, but specific guidelines were not provided for high resolution mass spectrometry (HRMS). With recent technical advances in HRMS and its increased use in the analysis of foods and veterinary medicines, it is imperative to supplement the existing guidance so that users of HRMS are consistent in evaluating and comparing results for regulatory use. This new guidance will harmonize the interpretation of the HRMS data across all of OFVM. In addition, as multi-class, multi-residue methods are commonly used within OFVM, this supplemental guidance will cover more than just veterinary drugs, e.g., pesticides, chemical contaminants, and natural toxins.
The methods below are at various stages in the validation processes of FDA's Foods and Veterinary Medicine Program. As Agency scientists complete the procedures and achieve the desired level of validation, they will be posted to the appropriate methods sections above. Please be aware that some of these projects will not result in a method suitable for regulatory use by the FDA, and some validations may require 1 to 2 years or longer in order to reach their end point. The reader is encouraged to check back frequently if there is interest in any of the methods listed.
|Isolation and Identification of Non-tuberculosis Mycobacteria from Tatoo Inks and Environmental Samples||Non-tuberculosis Mycobacteria||Tattoo inks, environmental samples|
|Real-time PCR for Detection of Listeria in Produce and Cheese||Listeria||Produce and cheese|
|Real-time PCR for Detection and Serogrouping of Listeria from Enrichment Broth Samples||L. monocytogenes||Produce and cheese|
|Isolation and Identification of Campylobacter from Raw Milk||Campylobacter jejuni and Campylobacter coli||Raw milk|
|Loop-Mediated Isothermal Amplification (LAMP) for screening of Salmonella from Animal Feed and Pet Food||Salmonella||Animal feed, pet food|
|Salmonella Serotyping using Multiplex PCR||S. enterica||Bacterial Isolates|
|SeqSero, a web-based application for Salmonella Serotyping||Salmonella||WGS data|
|EAM 4.7 Inductively Coupled Plasma-Mass Spectrometric Determination of Arsenic, Cadmium, Chromium, Lead, Mercury, and Other Elements in Food Using Microwave Assisted Digestion||Elements: As, Cd, Pb, Hg, Cr, Mn, Mo, Ni, Se, Zn, Cu||Foods|
|Determination of FDA Regulated Mycotoxins in Corn, Peanut Butter, and Wheat Flour Using Stable Isotope Dilution and Liquid Chromatography-Tandem Mass Spectrometry||12 mycotoxins||Corn, Peanut Butter, Wheat Flour|
|Sterols and Stanols in Foods and Dietary Supplements Containing Added Phytosterols||Sterols and Stanols||Foods|
|Determination of Sulfites in Food Using Liquid Chromatography-Tandem Mass Spectrometry||Sulfite||Foods|
|Antibiotic Residues in Distiller’s Grain Using Liquid Chromatography-Tandem Mass Spectrometry||Erythromycin A, penicillin G, virginiamycin M1, virginiamycin S1||Distiller's Grain|
|Analysis of copper salts as a color additive in olives||Cu||Olives|
|Analysis of glyphosate using LC-MS/MS||Glyphosate, glufosinate, AMPA||Soy, Corn, Eggs, Wheat|
Colors (FD&C) and Color Additives
FDA's Bacteriological Analytical Manual (BAM) presents the agency's preferred laboratory procedures for microbiological analyses of foods and cosmetics. As new methods are validated for use in FDA laboratories, there is a delay before chapters are updated and they are added to the BAM. In these instances, the new methods will be listed individually below until the BAM has been updated.
- Confirmation of Salmonella isolates by Real-time Polymerase Chain Reaction (PCR) (PDF: 562KB)
- Concentration, Extraction, and Detection of Norovirus and Hepatitis A virus in Soft Fruit (PDF: 389KB)
- Concentration, Extraction, and Detection of Norovirus and Hepatitis A virus in Molluscan Shellfish (PDF: 282KB)
- Screening of Salmonella in Animal Food by Loop-mediated Isothermal Amplification (LAMP) (PDF: 859KB)
- Concentration, Extraction, and Detection of Norovirus and Hepatitis A virus in Scallops and Finfish Meat (PDF: 292KB)
The Regulatory Fish Encyclopedia (RFE) is a compilation of data in several formats that assists with the accurate identification of fish species. It was developed by FDA's RFE Team of scientists at the Seafood Products Research Center (SPRC, Seattle District), and the Center for Food Safety and Applied Nutrition (CFSAN) to help federal, state, and local officials and purchasers of seafood identify species substitution and economic deception in the marketplace. Information and methods in the RFE include visual images, chemical taxonomic data, tissue protein profiles (Isoelectric Focusing Electrophoresis, IEF), and DNA sequence patterns (DNA Barcoding).
The Macroanalytical Procedures Manual includes methods for detecting filth, decomposition, and foreign matter in regulated products, including methods of inspection using the unaided senses (sight, smell, taste) or microscopy.
Levels of natural or unavoidable defects in foods that present no health hazards for humans. Each listing indicates the analytical methodology (Defect Method) used, as well as the parameters for the defect (Defect Action Level).
The National Shellfish Sanitation Program (NSSP) is the federal/state cooperative program recognized by the U. S. Food and Drug Administration (FDA) and the Interstate Shellfish Sanitation Conference (ISSC) for the sanitary control of shellfish produced and sold for human consumption. The purpose of the NSSP is to promote and improve the sanitation of shellfish (oysters, clams, mussels and scallops) moving in interstate commerce through federal/state cooperation and uniformity of State shellfish programs. The NSSP Guide for the Control of Molluscan Shellfish contains lists of Approved Methods for Marine Biotoxin Testing (page 276), and Approved Limited Use Methods for Marine Biotoxin Testing (page 278). Method references are in the footnotes of the table.